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Acute on Chronic Liver Failure (ACLF)Phase 1/2NCT07429838

RENEW: Study of Porcine Liver Support in Participants With Acute-on-Chronic Liver Failure

A Phase 1/2 study testing metra® Extracorporeal Liver Cross-Circulation (ELC) system (OrganOx) and EGEN-5784 (genetically engineered porcine liver) in people with Acute on Chronic Liver Failure (ACLF) and Hepatic Encephalopathy (HE), run by eGenesis, INC at 2 sites in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This is a Phase 1/2, first-in-human (FIH) safety, proof-of-concept, two-part study of the genetically-engineered EGEN-5784 liver in combination with the metra® extra-corporeal liver cross-circulation (ELC) system in participants with Grade 2 to Grade 3 acute-on-chronic liver failure (ACLF) and hepatic encephalopathy… Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
metra® Extracorporeal Liver Cross-Circulation (ELC) system (OrganOx) and EGEN-5784 (genetically engineered porcine liver)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesUnited States
Study dates
Oct 2026to Jan 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female, age 18 to 70 years, inclusive
  • Not eligible for transplantation at the time of enrollment
  • Diagnosis of Grade 2 to 3 ACLF according to the European Association for the Study of Chronic Liver Failure (EASL-CLIF) definition and Chronic Liver Failure Consortium-organ failure score (CLIF-C-OF) ≥10
  • Hepatic encephalopathy Grade 1 to 3 by West Haven Criteria
  • Written consent provided by participant or LAR (if participant lacks capacity, e.g., due to hepatic encephalopathy) prior to conduct of any study procedures

Who cannot join

  • Prior solid organ transplant
  • Fulminant hepatic failure without underlying liver disease
  • Non-biological artificial liver extracorporeal liver support (e.g., molecular adsorbent recirculating system) or bioartificial liver support systems within 30 days prior to EGEN-5784 liver perfusion
  • Liver dysfunction due to trauma, or extra-hepatic cholestasis
  • Any uncontrolled ongoing active infection
  • History or active human immunodeficiency virus (HIV) infection or acute hepatitis B virus (HBV)
Show all 12Show fewer
  • Chronic HBV or active hepatitis C
  • Diagnosis of cancer requiring active ongoing treatment, e.g., chemotherapy, radiation therapy
  • Severe concomitant cardiovascular disease defined as congestive heart failure Class III and IV
  • Significant acute or chronic pulmonary disease requiring ventilator support or diagnosed with chronic obstructive pulmonary disease Global Obstructive Lung Disease [GOLD] stage III or IV disorder
  • Active uncontrolled bleeding (i.e., any major blood loss requiring ≥2 units of pRBCs within the last 48 hours prior to screening)
  • Any other health condition, including illicit drug use, that would preclude participation in the study in the judgement of the PI

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Patient Inquires contact

617-941-7500

PatientInfo@egenesisbio.com

United States2 sites

  • University of Wisconsin

    Madison, Wisconsin, 53792

    David Foley, MD

  • Washington University

    St Louis, Missouri, 63130

    Jeffery Crippin MD

Other trials in United States

About this study

Official title: A Phase 1/2, First-in-Human Safety and Proof-of-Concept Study to Evaluate EGEN-5784 Porcine Liver (Drug Product) in Combination With the Metra® Extra-Corporeal Liver Cross-Circulation System in Participants With Acute-on-Chronic Liver Failure

This is a Phase 1/2, first-in-human (FIH) safety, proof-of-concept, two-part study of the genetically-engineered EGEN-5784 liver in combination with the metra® extra-corporeal liver cross-circulation (ELC) system in participants with Grade 2 to Grade 3 acute-on-chronic liver failure (ACLF) and hepatic encephalopathy Grade 1-3. The metra® device has been modified for the purposes of cross-circulation with an extra-corporeal porcine liver. The EGEN-5784 liver and metra® ELC system are designed to support liver function during the treatment period

Read the detailed description

This is a Phase 1/2, first-in-human (FIH) safety, proof-of-concept, two-part study of the genetically engineered EGEN-5784 liver in combination with the metra® extra-corporeal liver cross-circulation (ELC) system in participants with Grade 2 to Grade 3 acute-on-chronic liver failure (ACLF) and hepatic encephalopathy Grade 1-3. The metra® device has been modified for the purposes of cross-circulation with an extra-corporeal porcine liver. The EGEN-5784 liver and metra® ELC system are designed to support liver function during the treatment period

In Part 1, up to 6 participants will be enrolled and undergo ELC for up to 2 centers in the US.

In Part 2, up to 14 participants will be enrolled and undergo ELC at approximately 8 centers in the US.

The study will assess the safety of the ELC used to support liver function in patients with acute on chronic liver failure. Safety will be assessed based on Adverse Events Serious Adverse Events during the 28 days post-ELC and for the duration of the study. Unanticipated adverse device effects will be assessed during the ELC. Liver-related laboratory parameters will be assessed during the ELC treatment, and during the follow up period.

Being tested
metra® Extracorporeal Liver Cross-Circulation (ELC) system (OrganOx), EGEN-5784 (genetically engineered porcine liver)
Keywords
Extra-corporeal live cross-circulation, Metra
Medical subject headings
Acute-On-Chronic Liver Failure, Hepatic Encephalopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • metra® Extracorporeal Liver Cross-Circulation (ELC) system (OrganOx)Device

    Also called OrganOx metra, OrganOx ELC, ELC system

    Perfusion circuit/device enabling extracorporeal cross-circulation between the participant and the EGEN-5784 porcine liver. Planned support up to 72 h in Part 1 and up to 120 h in Part 2 if no safety/stopping criteria are met, with ICU-level monitoring and protocol-defined operating parameters.

  • EGEN-5784 (genetically engineered porcine liver)Biological

    Also called xenogeneic porcine liver, EGEN-5784 liver, Genetically Engineered Porcine Liver

    Viable porcine liver from a genetically engineered donor (EGEN-5784) used for temporary extracorporeal cross-circulation support. The liver is not implanted; it is perfused in a closed circuit with the participant under continuous monitoring and predefined stopping rules per protocol.

Study groups in NCT07429838
Study groupRoleWhat they receive
EGEN-5784 + metra® Extracorporeal Liver Cross-Circulation (ELC)ExperimentalParticipants with Grade 2-3 ACLF receive extracorporeal cross-circulation using a genetically engineered porcine liver (EGEN-5784) connected via the metra® ELC system, in addition to institutional standard of care. No comparator arm is included
Receives: Device: metra® Extracorporeal Liver Cross-Circulation (ELC) system (OrganOx); Biological: EGEN-5784 (genetically engineered porcine liver)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of TESAE's

    Incidence of Treatment-Emergent Serious Adverse Event

    Measured: From ELC initiation to 28 days post-ELC initiation

  2. Incidence of AESIs

    Incidence of Adverse Event of Special Interest

    Measured: From ELC initiation through 28 days post ELC initation

  3. Incidence of Device Deficiencies

    Measured: From metra® initiation through metra® ELC termination (assessed continuously during the ELC procedure; up to 72 hours in Part 1 and 120 hours in Part 2)

  4. Incidence of UADEs

    Incidence of Unanticipated Adverse Device Effect

    Measured: From metra® initiation through metra® ELC termination (assessed continuously during the ELC procedure; up to 72 hours in Part 1 and 120 hours in Part 2)

Secondary outcomes (5)

  1. Change in blood ammonia (NH₃), measured in µmol/L

    Measured: From Baseline to 28 days post ELC initiation

  2. Change in total bilirubin and direct bilirubin measured in mg/dL

    Measured: From Baseline to 28 days post ELC initiation

  3. Change in coagulation parameters, measured by international normalized ratio (INR)

    Measured: From Baseline to 28 days post ELC initiation

  4. Change in ACLF score

    Measured: From Baseline to 28 days post ELC initiation

  5. Change in West Haven criteria for hepatic encephalopathy

    Measured: Baseline to 28 days post ELC initiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionDec 2027 (estimated)
  4. Study completionJan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07429838
Sponsor's protocol ID
EGEN-5784-CL-1001
Status last verified
Sep 2026
First submitted
8 Jan 2026
Last updated
21 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing metra® Extracorporeal Liver Cross-Circulation (ELC) system (OrganOx) and EGEN-5784 (genetically engineered porcine liver) in people with Acute on Chronic Liver Failure (ACLF) and Hepatic Encephalopathy (HE), run by eGenesis, INC at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Patient Inquires (617-941-7500, PatientInfo@egenesisbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of TESAE's (time frame: From ELC initiation to 28 days post-ELC initiation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07429838.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.

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